Job Description

ONLY CANDIDATES THAT HAVE MINIMUM 4 YEARS OF WORK EXPERIENCE IN API MANUFACTURING SITE WILL BE CONSIDERED FOR THE ROLE.Candidates predominantly with Formulation experience will NOT be considered.Senior Officer / Executive / Senior Executive in Quality Assurance Department for IPQA, QMS, Audit and Compliance.
Qualification: BSc/ BPharm /MSc /MPharm.
Experience: 5 - 8 years
Salary: 4,00,000.00 - 6,00,000.00Exposure to local GMP / Audit & Compliance / QMS Activity / Validations activity / Gap assessments / RCA / Risk Assessment / Vendor Qualifications / Equipment & Instrument Qualifications / Sampling / Analytical validation and other non-routine validation activities / Process Validation / Dispensing activities / Review Validation Master Plan / Deviation / Change Control / Analytical Quality Assurance / Cleaning Validation / APQR / Investigations / CMO activities / Regulatory & Non Regulatory Audit / Internal Audit / Local Audit / FDA audit / IPQA / BMR / BPR review / other key functions of QA and any other activity as designated by HOD.Should be well versed with cGMP environment & current regulatory guidelines. Should have knowledge of ICH guidelines, audits by regulatory agencies such as WHO, US-FDA, EDQM/EU etc.Job Type: Full-timeSalary: 9400,000.00 - 9600,000.00 per yearBenefits:

• Provident Fund

• Day shift

• How many total years of work experience do you have?
• Are you currently working in Active Pharmaceutical Ingredient (API) manufacturing plant?
• How many years of work experience do you have in API manufacturing plant?
• Are you comfortable commuting to this job's location?
• Do you have expertise in Audit & Compliance?
• Do you have expertise in IPQA?
• Do you have expertise in Quality Management System QMS?
• How many years of work experience do you have using ICH guidelines?
• If offered the role, Can you join within 15 days?
• If offered the role, Can you join within 30 days?
• Are you comfortable with the salary range stated in the advertisement?
• Are you willing to work in rotational Shifts if required?